Systems and methods for puncture closure

• US 8,366,706 B2
• Filed: 08/15/2008
• Issued: 02/05/2013
• Est. Priority Date: 08/15/2007
• Status: Expired due to Fees

• Current Assignee: Cardiodex, Ltd.
• Original Assignee: Cardiodex, Ltd.
• Inventors: Buchbinder, Maurice, Yadin, Amnon, Mizrahi, Noam, Eckhouse, Shimon, Goldberg, Eran, Cohen, Aharon, Logan, Julie
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US12/192,911
• Publication Number:
  US 20090125056A1
• Time in Patent Office: 1,635 Days
• Field of Search: None
• US Class Current: 606/27
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: B23P 6/00 Restoring or reconditioning objects straightening or restoring form of sheet metal, metal rods, metal tubes, metal profiles, or specific articles made therefrom B21D1/00, B21D3/00; repairing defective or damaged objects by casting techniques B22D19/10
• CPC Class Codes: Y10T 137/598 With repair, tapping, assembly, or disassembly means

Abstract

Systems, apparatuses and methods are provided for use in closing punctures in vessel walls. An apparatus may have various combinations of an anchoring device, a positioning device and a heating element for closing a puncture within a vessel wall. An anchoring device may be a balloon, an expansible cage, a wire operated T-anchor, and/or a floating anchor. A positioning device may be a balloon, a sponge, and/or an expansible cage. A heating element may be flexible or rigid and preferably provides heat to target tissue through conduction and convection. A heating element may be flat-ended or dome-shaped. The heating element and anchoring device may be positioned a fixed distance apart to sandwich tissue between the heating element and the anchoring device. The heating element may operate in multiple stages. An initial stage may non-permanently adhere the heating element to the tissue and the subsequent stage may close the puncture.

Claims

1. An apparatus for closing a puncture in a vessel wall comprising:

an anchor shaft having a distal end and a tip,

an anchor disposed on the distal end of the anchor shaft, a distal end of the anchor is proximally spaced apart from the tip of the anchor shaft and adapted for being in a deployed position and un-deployed position, wherein the anchor is adapted for being in the deployed position within a vessel lumen and is further adapted for being moved into contact with an inner surface of a vessel wall, and

an approximately dome-shaped heating element having a lumen and a distal opening for passing the heating element over the anchor shaft, wherein the tip of the anchor shaft is seated in the heating element upon retraction of the anchor shaft, the heating element adapted for being disposed outside the vessel wall, the heating element and the deployed anchor being adapted for disposing the vessel wall there between and wherein the heating element is capable of heating when the anchor is deployed and when the anchor is un-deployed.

2. The apparatus of claim 1, further comprising a trigger to lock a relative position of the heating element and the anchor.

3. The apparatus of claim 1, wherein the heating element is approximately spherical for positioning over the puncture in the vessel wall and above the anchor device.

4. The apparatus of claim 1, wherein the heating element includes a conducting dome and a conducting element disposed within the conducting dome.

5. The apparatus of claim 1, wherein the heating element comprises a metal conducting dome and a disc-shaped conducting element.

6. The apparatus of claim 1, wherein the heating element and the anchor are coaxially disposed and are positionable to compress the vessel wall therebetween.

7. The apparatus of claim 1, wherein the vessel wall and tissue are adapted to be sandwiched between the heating element and the deployed anchor.

8. The apparatus of claim 1, further comprising:

a pass-through device at least partially surrounding the anchor shaft for facilitating passage of the heating element over the anchor shaft into proximity with the outer surface of the vessel wall opposite the anchor.

9. The apparatus of claim 1, wherein the anchor shaft has an anchor shaft circumference and the tip has a circumference larger than the anchor shaft circumference.

10. The apparatus of claim 1, wherein the heating element is a resistant heating element.

11. The apparatus of claim 1, wherein the tip of the anchor shaft has a diameter of approximately 2 mm and wherein a diameter of the lumen of the heating element is approximately 1.3 mm.

12. The apparatus of claim 1, wherein a diameter of the lumen of the heating element is approximately 1.0-1.3 mm.

13. The apparatus of claim 1, wherein the tip of the anchor shaft is seated in the heating element so it is prevented from being withdrawn from the patient until the heating element is withdrawn.

14. The apparatus of claim 1, wherein the distal opening of the heating element is angled and wherein the angled opening relative to the anchor shaft is less than 45 degrees.

15. The apparatus of claim 1, wherein the apparatus further comprises a guide wire.

16. The apparatus of claim 1, wherein the tip of the anchor shaft is flush with the distal end of the heating element.